BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

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The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Change From Baseline in HbA1c After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

Change from baseline in HbA1c after 12 weeks of treatment.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Secondary Outcome Measures
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Change of FPG From Baseline After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Change of HbA1c From Baseline Over Time [ Time Frame: Baseline and weeks 4, 8 and 12 ]

Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.

Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression

Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]

Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression

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Ages Eligible for Study:

18 Years to 79 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug

Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.

HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only

HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)

Age >=18 and <80years

Body Mass Index (BMI) <=40 kg/m2

Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent

Alcohol abuse or drug abuse

Treatment with an investigational drug within 2 months prior to informed consent

Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial